FDA 510(k)

NeoFuse Ti3D PLIF/TLIF/Cervical Interbody

Número K: K170318 · 2017-07-12

Data da decisão2017-07-12

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical, LLC. It received FDA 510(k) clearance on 2017-07-12 under 510(k) number K170318. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NeoFuse Ti3D PLIF/TLIF/Cervical Interbody?

NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is a medical device that received FDA 510(k) clearance on 2017-07-12. The listed applicant is Ht Medical, LLC. The 510(k) number is K170318.

When did NeoFuse Ti3D PLIF/TLIF/Cervical Interbody receive FDA 510(k) clearance?

NeoFuse Ti3D PLIF/TLIF/Cervical Interbody received FDA 510(k) clearance on 2017-07-12, under 510(k) number K170318.

Who is the listed applicant for NeoFuse Ti3D PLIF/TLIF/Cervical Interbody?

The FDA 510(k) record lists Ht Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeoFuse Ti3D PLIF/TLIF/Cervical Interbody?

The FDA product code for NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is ODP.

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Outros registros que listam Ht Medical, LLC como candidato(a)

K170511NeoFuse HA Enhanced PLIF/TLIF K153615NeoFuse HA Enhanced PLIF/TLIF

Dispositivos Relacionados (Código: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Fonte oficial

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